Clinical trials: Apnea, Sleep
Obstructive Sleep Apnea
Field Usability Study of Eclipse Mask
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05559047
- Testing
- Eclipse mask
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Validation Study, VGH
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional…
- Trial name
- NCT06474390
- Where
- Taiwan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Sleep Disorders
Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory
Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated.
- Trial name
- NCT01570738
- Where
- Israel
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Itamar-Medical, Israel
Sleep Apnea
A Validation Study of the NightOwl Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04764734
- Testing
- NightOwl
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Sleep Apnea Syndromes
Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment
The sleep apnea-hypopnea syndrome is characterized by the occurrence, during sleep, of abnormally frequent episodes of interruption of ventilation (apnea), or significant reduction in ventilation (hypopnea).
- Trial name
- NCT05477719
- Testing
- Wearing of specific compression stockings
- Where
- France
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sigvaris France
Obstructive Sleep Apnea, Obstructive Sleep Apnea-hypopnea
Updating Deep Learning Algorithms for OSA Monitoring
The objective is to enhance the reliability of the algorithm to match that of Level 1 polysomnography by leveraging the diverse data obtained from Level 1 polysomnography to refine the deep learning algorithm.
- Trial name
- NCT06522815
- Testing
- CART-I plus, Polysomnography
- Where
- South Korea
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Sky Labs
Obstructive Sleep Apnea
Humidification Needs
A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by…
- Trial name
- NCT03247907
- Testing
- Condition A: CPAP with No Humidification, Condition B: CPAP with No Humidification, Condition C: CPAP with Cold Passover
- Where
- New Zealand
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the…
- Trial name
- NCT01797705
- Testing
- DeVilbiss AutoAdjust CPAP with revised algorithm
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- DeVilbiss Healthcare LLC
Sleep Apnea
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Obese, Sleep Apnea, Obstructive
Eval EarlySense Bet Lowenstein Sleeplab
The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs.
- Conditions
- Obese, Sleep Apnea, Obstructive, Central Apnea, Sleep Disorders
- Trial name
- NCT01978340
- Where
- Israel
- Volunteers
- healthy volunteers welcome
- Sponsor
- EarlySense Ltd.
Sleep Apnea
Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea.
- Trial name
- NCT03775291
- Testing
- Simultaneous assessment of sleep apnea by polysomnogram and wearable device
- Where
- 6 sites in United States, Ireland
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Fitbit LLC
Sleep-Disordered Breathing
Polysomnography Validation of the Sansa Device
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
- Trial name
- NCT06070389
- Testing
- Sansa device
- Where
- 2 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Huxley Medical, Inc.
Cardiovascular Diseases, Cardiovascular Diseases Risk
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm…
- Conditions
- Cardiovascular Diseases, Cardiovascular Diseases Risk, Cardiac Conduction System Disease, Bundle/Fascicular Abnormalities
- Trial name
- Cor360 (NCT07775976)
- Testing
- COR Wearable ECG Monitoring, Cor360 Clinician-Facing Decision-Aid Reporting
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Sleep Apnea
Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test
Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.
- Trial name
- NCT03385187
- Testing
- NightOwl HSAT
- Where
- Belgium
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Obstructive Sleep Apnea
Comprehensive Analysis of Respiratory Events Using Smartphone Systems
Earlier studies suggest that acoustical analysis of snoring sounds can identify obstructive sleep apnea (OSA). The goal of the current study is to refine and validate algorithms for OSA diagnosis.
- Trial name
- CARESS (NCT03457428)
- Where
- 4 sites in United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Resonea, Inc
Obstructive Sleep Apnea
Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
The goal of this observational study is to characterize the performance of the SleepView+ home sleep test system for the evaluation of moderate to severe obstructuve sleep apnea (OSA) in adult and pediatric patients (ages 12 and…
- Trial name
- NCT07476313
- Testing
- SleepView+
- Where
- 4 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Beacon Biosignals
Obstructive Sleep Apnea
Skiin-PSG Sleep Apnea
The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the…
- Trial name
- NCT06247878
- Testing
- Skiin underwear chest band
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Myant Medical Corp.
Sleep Apnea
Evaluation of Compumedics "Somfit" Device
To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
- Trial name
- NCT04326127
- Testing
- Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Compumedics Limited
Obstructive Sleep Apnea
Developement of TipTraQ Home Sleep Test
The clinical study aims to develop and fine-tune the TipTraQ system, created by PranaQ, for home sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and…
- Trial name
- NCT06474351
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
OSA
Continuation Protocol for Obstructive Sleep Apnea (OSA)
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA).
- Trial name
- NCT06566820
- Testing
- Aroxybutynin and Atomoxetine
- Where
- 99 sites in United States, Canada
- Volunteers
- 1,280 people, healthy volunteers welcome
- Sponsor
- Apnimed